An Online Large-group One-session Training to Enhance Positive Mental Health

April 26, 2022 updated by: Svenja Schaumburg, Ruhr University of Bochum

The More the Merrier and Brevity is the Soul of Wit? Efficacy of a Multicomponent Positive Psychological Intervention Conducted in an Online Large-group One-session Format

Current models suggest that mental health is not the mere absence of a mental disorder. Rather, mental health consists of two factors, mental disorder symptoms and positive mental health, that can be regarded as continua. Programmes applying interventions known from the positive psychology or positive psychotherapy framework have been shown to enhance psychological wellbeing, subjective wellbeing and to reduce depressive symptoms. However, interventions were mostly conducted in an individual or small group setting and usually consisted of more than one session. The few trainings of minimal length that were conducted in group settings only used one intervention strategy or one part of multicomponent positive psychological interventions. Therefore, the conclusions that can be drawn regarding the effectiveness of short group-interventions are limited. In this study, the investigators plan to conduct an online large-group one-session training to enhance positive mental health that comprises multiple positive psychological interventions (e.g. character strengths, positive communication, goal attainment, etc). Furthermore, an active as well as a passive (waitlist) control group are included in the study. In the active control group, dysfunctional thoughts are adressed that are known to everybody but exist in a great measure in people suffering from depressive disorders. Methods used in cognitive therapy are applied in this group. Participants will be recruited from a community sample without any inclusion criteria but being of legal age. The only exclusion criterion is not having the appropriate technical equipment for participation in a videoconference. Positive mental health as well as other constructs of mental health will be assessed before and after training and at one month and six months follow up to investigate long-term effects of the intervention.

Study Overview

Detailed Description

In general, the investigators expect an increase in positive mental health in the multicomponent positive psychological intervention (MPPI) group. This effect should be present at the assessment points one month and six months after training. Furthermore, the increase in positive mental health in the MPPI group is expected to be larger than in the two control groups (cognitive intervention targeting dysfunctional thoughts [CIDT], waitlist). Furthermore, the investigators hypothesize participants to benefit from the MPPI in terms of other constructs related to mental health, i.e. self efficacy, happiness, wellbeing, positive emotions, and life satisfaction, in the long term. This increase is expected to be larger in the MPPI than in the two control groups. A decrease in depressive symptoms is hypothesized to occur in the MPPI as well as in the CIDT group.

The sample under investigation will be a community sample. All participants can attain the training for free and there is no payment for participation. One week before the first training day, the random allocation to the three groups will take place. Two days before the first training day, all participants are asked to fill out another survey through a link sent to them via e-mail. This survey comprises all outcome measures. The same procedure is carried out one day after, one month after and six months after the first training day. After the last assessment time point, the training for the waitlist control group will be conducted.

The target sample size is 300 participants (100 per group). The investigators will attempt to recruit more participants, assuming that not all will complete the study, especially the assessment after six months.

The investigators used the software program G*Power to conduct a power analysis. The goal was to obtain .95 power to detect a small effect size of .1 at the standard .05 alpha error probability. The investigators extended the calculated sample size of 264 participants to a target sample size of 300 participants as there was no study before that compared an online multicomponent large-group one-session training to enhance positive mental health with an online large-group one-session intervention targeting dysfunctional thoughts. Therefore, the effect size for the comparison of these two groups could be smaller than f = .1.

The primary outcome measure will be analyzed with a 3x2 repeated measures ANOVA.

For all other outcome measures, the investigators will use 3 x 4 between-within repeated measures ANOVAs (rmANOVA) to analyze the results. The first factor is a between-subjects factor that comprises the three groups MPPI, CIDT and waitlist control group. The second factor is a within-subjects factor reflecting the four assessment time points two days before the intervention, one day after the intervention, one month after the intervention and six months after the intervention. This analysis will be conducted for positive mental health, life satisfaction, affect, generalized self-efficacy, happiness, wellbeing, stress perception, positive and negative aspects of mental health, depression, anxiety and stress, social support and media-related variables. Before these analyses are carried out, correlations among the outcome measures are calculated. If outcome measures correlate significantly high (above .5), they will be first analyzed together in a between-within repeated measures MANOVA to control for alpha-error accumulation. After that, the separate analyses will be conducted. Furthermore, there will be paired comparisons between each of the three groups, reducing the first between-subjects factor in the between-within rm(M)ANOVA to two levels. For each group, rmANOVAs will be conducted to analyze the change of outcome variables over time entailing paired contrasts between the assessment time points.

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bochum, Germany, 44801
        • Ruhr-University of Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Aged 18 years or above

Exclusion Criteria:

• Not having the appropriate technical equipment for participation in a videoconference

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Waitlist Control Group
EXPERIMENTAL: Online large-group one-session multicomponent positive psychological intervention
The intervention is aimed at enhancing positive mental health by using components from positive psychology or positive psychotherapy. These include for exapmle using character strengths, savoring the moment, goal setting and goal attainment. The intervention is conducted in an online group format via videoconference with a duration of approximately 3 and a half hours.
ACTIVE_COMPARATOR: Online large-group one-session cognitive intervention targeting dysfunctional thoughts
The intervention is aimed at reducing dysfunctional thoughts by applying strategies known from the cognitive therapy of depression. These include for example identification of automatic thoughts and cognitive biases as well as evaluating evidence for and against automatic thoughts. The intervention is conducted in an online group format via videoconference with a duration of approximately 3 and a half hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change on positive mental health scale (german version; Lukat, Margraf, Lutz, van der Feld, & Becker, 2015)
Time Frame: two days before the intervention and one month after the intervention
9 items, 4-point Likert scale, large change in a positive direction means better outcome
two days before the intervention and one month after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change on positive mental health scale (german version; Lukat, Margraf, Lutz, van der Feld, & Becker, 2015)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention (already specified as primary outcome measure), six months after the intervention
9 items, 4-point Likert scale, large change in a positive direction means better outcome
two days before the intervention, one day after the intervention, one month after the intervention (already specified as primary outcome measure), six months after the intervention
change on generalized self efficacy scale (german version; Schwarzer & Jerusalem, 1999)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
10 items, 4-point Likert scale, large change in a positive direction means better outcome
two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on satisfaction with life scale (german version; Glaesmer, Grande, Braehler, & Roth, 2011)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
5 items, 7-point Likert scale, large change in a positive direction means better outcome
two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on subjective happiness scale (Lyubomirsky & Lepper, 1999; german version)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
4 items, 7-point Likert scale, large change in a positive direction means better outcome
two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on positive and negative affect schedule (german version; Breyer & Bluemke, 2016)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
20 items, 5-point Likert scale, two subscales negative affect: large change in a negative direction means better outcome positive affect: large change in a positive direction means better outcome
two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change in the degree of subjectively experienced stress concerning a specific situation measured with the questionnaire "primary appraisal secondary appraisal" (PASA; german version; Gaab, 2009)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention

The questionnaire assesses the two processes proposed in Lazarus' transactional model of stress: primary appraisal and secondary appraisal. Each process is operationalized by two subscales (yielding four level 1 subscales and two level 2 subscales). The subscales will be analyzed seperately and a stressindex will be calculated by calculating the difference between primary and secondary appraisal.

16 items, 6-point Likert-scale, for the stressindex, large changes in a negative direction mean better outcome

two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on mental health continuum - short form (Keyes et al., 2008; german translation)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
14 items, 6-point Likert scale, three subscales emotional wellbeing, subjective wellbeing and personal wellbeing, large change in a positive direction means better outcome
two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on general health questionnaire (german version; Linden et al., 1996)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
12 items, 4-point Likert scale, large change in a negative direction means better outcome
two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on depression anxiety stress scale (DASS-21; german version; Nilges & Essau, 2015)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
21 items, 4-point Likert scale, 3 subscales that are analyzed separately (depression, anxiety, stress), large change in a negative direction means better outcome
two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on brief form of the perceived social support questionnaire (german version; Lin, Hirschfeld, & Margraf, 2019)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
6 items, 5-point Likert scale, large change in a positive direction means better outcome
two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change of frequency of media use (TV, internet, gaming, smartphone, social media)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
7-point scale for each medium, large change in a negative direction means better outcome
two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change of use of social media (frequency of social media use of different platforms, e.g. facebook, tumblr; accesses per day; time per day)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
frequency: 7-point scale, accesses per day and time per day measured continously, large change in a negative direction means better outcome
two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on brief version of the Bergen Social Media Addiction Scale (german version; Brailovskaia, Schillack, & Margraf, 2020)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
6 items, 5-point Likert scale, large change in a negative direction means better outcome
two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
general rating of success
Time Frame: one day after the intervention
how helpful was the training for you (0 = not helpful at all; 10 = extremely helpful); how successful was the training for you ( 0 = not successful at all; 10 = extremely successful); did the training meet your expectations (0 = did not meet my expectations at all; 10 = met all my expectations); would you recommend the training to a friend (0 = would not recommend it; 10 = would absolutely recommend it)
one day after the intervention
practice / use of the learned strategies
Time Frame: one month after the intervention, six months after the intervention
how often did you practice / use the learned strategies (0 = never; 10 = always)
one month after the intervention, six months after the intervention
helpfulness of the learned strategies
Time Frame: one month after the intervention, six months after the intervention
how helpful was the use of the learned strategies (0 = not helpful at all; 10 = extremely helpful)
one month after the intervention, six months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Svenja Schaumburg, M. Sc., Ruhr University of Bochum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ACTUAL)

May 1, 2021

Study Completion (ACTUAL)

October 17, 2021

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (ACTUAL)

February 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It is planned to make individual participant data available on publication of the associated study results, via a publically-available data repository such as Open Science Framework. Data made available will be the research data reported in the publication, with the exception of any data that could compromise participant anonymity.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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